Senior Engineer

Amgen•Thousand Oaks, CA

10d•Remote

About The Position

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Senior Engineer What you will do and what we expect of you Let’s do this. Let’s change the world. In this vital role you will: Duties: Lead or support new product introductions and lifecycle changes into Amgen Thousand Oaks drug product manufacturing facility as the Process Development lead by integrating products' process design and requirements with the site's procedures and capabilities; Collaborate with multiple plant functions to ensure the aseptic fill finish equipment and procedures that constitute the DP platform processes are fully characterized to enable efficient and successful tech transfers of Amgen's clinical & commercial product portfolio; Act as point contact to provide knowledge of clinical and commercial manufacturing site process capabilities and practices; Support make-a-batch exercises to determine facility fit and identify gaps; Design, implement and document off-line and on-site DP characterization studies; Design, plan, and provide floor support to engineering, machinability, and process performance qualifications (PPQ) runs required to ensure successful product commercialization; Author and own high-quality process technology transfer and other technical documents; Development of validation plans and supports execution of PPQs for commercial manufacturing; Authors and reviews process validation protocols, assessments and reports within Amgen's quality systems; and Supporting regulatory filings and health authority interactions as an SME including writing responses and participating in regulatory audits. Supervises direct reports. May telecommute.

Requirements

Master’s degree (or foreign degree) in Chemical Engineering, Biotechnology, or related field & 2 years in the job offered or in an engineering related occupation.
Transferring drug product processes of parenteral drug products including biologics or vaccines to fill or finish GMP Manufacturing for clinical and commercial use, integrating and monitoring developed processes to plant procedures and equipment capabilities post transfer and lead Life Cycle Management (LCM) initiatives
Designing, planning, executing, or documenting in silico, off-line, or on-line characterization studies and integrating established process operating ranges in recipes or batch records
Improving manufacturing performance by establishing monitoring programs, routinely checking for trends, or identifying process improvements and exploring new technologies
Implementing Corrective and Preventive Actions (CAPAs) and change controls using Trackwise, Integrated Document Management (IDM) or Organizational Change Management (OCM) systems
Investigating process deviations to identify root causes and causal factors using tools including: Level 0, Fishbone analysis, or contradiction matrix
Designing and supporting studies that are used in regulatory filings that meet the applicable regulations from FDA, EU, or global standards and conduct internal audits to prepare plant for pre-approval inspections (PAI)
Technical knowledge and knowledge of validation for regulatory filings, audits, or inspections

Responsibilities

Lead or support new product introductions and lifecycle changes into Amgen Thousand Oaks drug product manufacturing facility as the Process Development lead by integrating products' process design and requirements with the site's procedures and capabilities
Collaborate with multiple plant functions to ensure the aseptic fill finish equipment and procedures that constitute the DP platform processes are fully characterized to enable efficient and successful tech transfers of Amgen's clinical & commercial product portfolio
Act as point contact to provide knowledge of clinical and commercial manufacturing site process capabilities and practices
Support make-a-batch exercises to determine facility fit and identify gaps
Design, implement and document off-line and on-site DP characterization studies
Design, plan, and provide floor support to engineering, machinability, and process performance qualifications (PPQ) runs required to ensure successful product commercialization
Author and own high-quality process technology transfer and other technical documents
Development of validation plans and supports execution of PPQs for commercial manufacturing
Authors and reviews process validation protocols, assessments and reports within Amgen's quality systems
Supporting regulatory filings and health authority interactions as an SME including writing responses and participating in regulatory audits
Supervises direct reports

Benefits

stock
retirement
medical
life and disability insurance
eligibility for an annual bonus
health and welfare plans for staff and eligible dependents
financial plans with opportunities to save towards retirement or other goals
work/life balance
career development opportunities
Retirement and Savings Plan with generous company contributions
group medical, dental and vision coverage
flexible spending accounts
discretionary annual bonus program
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models, including remote and hybrid work arrangements, where possible